Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

Arrhythmia Clinical Trial

Official title:

Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203333
• Other study ID #: J05901
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: October 17, 2016
• Start date: April 2002
• Est. completion date: January 2010

Study information

• Verified date: October 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP.

This study plans to determine:

1. the frequency and types of cardiac arrhythmias that occur in this population and

2. whether these are increased above the general population in the same age group.

Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.

Description:

By employing long-term electrocardiographic monitoring, this study plans to determine:

1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and

2. whether these are increased above the general population in the same age group.

The specific aims:

1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.

2. Correlate abnormal heart rates and rhythms to specific clinical data:

1. seizure type,

2. seizure frequency,

3. probable location of seizure onset in the brain, when such data are available,

4. duration of seizures, and

5. type(s) and number of anticonvulsant medications being used.

3. Correlate cardiac arrhythmias to clinical symptoms

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2010
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 49 Years

Eligibility

Inclusion Criteria:

• Refractory epilepsy

Exclusion Criteria:

• Other pre-existing heart conditions

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Death
• Death, Sudden
• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy
• Sudden Death

Intervention

Device:
• Medtronic REVEAL

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18. — View Citation